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Nucala: First and only severe eosinophilic asthma biologic indicated from age 6¹
The licensed dose of Nucala in children aged 6-11 years is 40mg SC as a lyophilised powder, regardless of weight.¹
The safety profile of Nucala in paediatric patients was similar to that seen in adults²
Study 2003636 Part A: Adverse events in children aged 6-11 years
Number (%) of subjects³
AEs, n (%)³
|
Nucala 40 mg SC n=26 |
Nucala 100 mg SC n=10 |
Overall |
| Any AE |
20 (77) | 6 (60) | 26 (72) |
| Related to study treatment | 8 (31) | 3 (30) | 11 (31) |
| Leading to withdrawal | 1 (4) |
0 | 1 (3) |
| Any SAE | 6 (23) | 1 (10) | 7 (19) |
| Related to study treatment | 2 (8) |
0 | 2 (6) |
| Fatal SAE | 0 | 0 | 0 |
| Any on-treatment AE | 18 (69) | 6 (60) | 24 (67) |
| Any on-treatment serious AE | 5 (19) | 1 (10) | 6 (17) |
Study 2003636 Part B: Adverse events in children aged 6-11 years
Number (%) of subjects³
| AEs, n (%) | Nucala 40 mg SC n=16 |
Nucala 100 mg SC n=10 |
Nucala 40/100 mg SCa n=4 |
Overall n=30 |
| Any AE |
15 (94) |
8 (80) | 4 (100) | 27 (90) |
| Related to study treatment | 4 (25) | 3 (30) | 1 (25) | 8 (27) |
| Leading to withdrawal | 0 | 0 | 0 | 0 |
| Any SAE | 4 (25) | 2 (20) | 1 (25) | 7 (23) |
| Related to study treatment | 0 | 0 | 0 | 0 |
| Fatal SAE | 0 | 0 | 0 | 0 |
| Any on-treatment AE | 15 (94) | 8 (80) | 4 (100) | 27 (90) |
| Any on-treatment serious AE | 4 (25) | 2 (20) | 1 (25) | 7 (23) |
In this open-label, uncontrolled, repeat-doseextension study, children aged 6-11
years with severe asthma with an eosinophilic phenotype received a body weight-dependent dose of SC Nucala of 40mg (<40kg) over 52 weeks.²
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.¹
Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.¹
The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁴
The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6-11 years is 40mg SC regardless of weight and available in lyophilised powder. The pre-filled formulations are are not indicated in 6-11 year olds.¹
SC, subcutaneously;
References
- Nucala SmPC 2020
- Stienfield J et al. Am J Respi Crit Care Med 2019; 199:A7192.
- GlaxoSmithKline data on file. REF-35199
- Khurana S et al. Clin Ther 2019; 41:2041-2056
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441
© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.
PM-GB-MPL-WCNT-200033 | November 2020
